POSITION SUMMARY:

The successful applicant will be responsible for building-out Minovia's Manufacturing & Supply Chain strategy in key markets globally aligned with the Company's strategy for growth. This is a challenging position offering the opportunity to contribute to the development and success of a truly innovative cell therapy company right from the beginning and to make a real difference to patients' lives.

THE HEAD OF MANUFACTURING & SUPPLY CHAIN WILL REPORT TO THE CHIEF FINANCIAL OFFICER & HEAD OF US OPERATIONS. Key aspects of the role include ensuring clinical supply for on-going in-human trials in a personalized cell therapy approach, building out the manufacturing capability & footprint (internally & externally) for our cell therapy platform worldwide, identifying and securing key supplier relationships for critical materials and equipment, preparing our manufacturing facilities for FDA approval in multiple indications, understanding and building out the most efficient, cost effective patient and product logistics flows, and preparing for commercial production.  The successful applicant will also be expected to help define and implement novel cell therapy manufacturing approaches that scale the operation over time and ensure a lower cost of goods. More broadly, he/she will participate in key decision-making for the company's manufacturing and supply chain activities through participation in the Company's core leadership team.

The successful candidate will be driven to thrive in an early-stage clinical biotech environment, be comfortable with ambiguity, require conceptual flexibility, POSSESS AN ENTREPRENEURIAL AND INNOVATIVE SPIRIT, AND BE VERY “HANDS-ON”. The successful candidate will be able to work collaboratively across time zones and functions, including R&D, Quality, Regulatory, and Clinical Operations.  The candidate will be both strategically and operationally strong.

This is an outstanding opportunity to have a broad influence on the leadership, development and success of Minovia as it builds its presence globally.

RESPONSIBILITIES:

• Develops and implements organization-wide and site-specific strategies for product development and manufacturing; ensures success of all production activities and projects including build-out, commissioning and qualification, facility start-up, and reliable clinical and future commercial manufacturing operations.
• Brings existing manufacturing sites up to FDA-compliant manufacturing/filing standards to enable approval in US, EU, and Japan.
• Responsible for long-range strategic planning for Minovia's manufacturing and supply chain operations; discusses and presents manufacturing plans/updates to the Executive team, the Board of Directors, and business partners, as required.
• Ensures all manufacturing and process validation activities are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.
• Provides input into regulatory submissions and regulatory approvals (e.g. NDA and MAA).
• In coordination with Reg CMC, leads the implementation of the overall CMC strategy for clinical to commercial stage products ranging from strategic sourcing, tech transfer, process validation, clinical supply, and commercial supply manufacturing.
• Negotiates and administers contracts with suppliers, and contract manufacturing organizations. Performs on-site visits as needed to key suppliers in North America, Asia, and Europe.
• Develops long-term strategies to establish and maintain a robust commercial supply chain, enact appropriate risk mitigation procedures, and monitor and identify future market trends.
• Identifies and implements operational performance metrics to improve efficiencies, manage cost of goods, and overall product quality of deliverables.
• Develops, oversees, and takes responsibility for manufacturing operational budgets and resource planning to meet market growth and associated business objectives.

REQUIREMENTS:

• BS OR ADVANCED DEGREE IN BIOLOGY, CHEMISTRY, OR ENGINEERING DISCIPLINES WITH A MINIMUM OF 10 YEARS OF RELEVANT EXPERIENCE IN BIOTECH OR PHARMACEUTICAL INDUSTRIES, IDEALLY IN A SENIOR MANUFACTURING LEADERSHIP ROLE IN A GMP FACILITY WITHIN THE BIOTECHNOLOGY OR PHARMACEUTICAL INDUSTRY; CELL OR GENE THERAPY EXPERIENCE PREFERRED.
• Leadership experience with clinical supply chain development, manufacturing strategy development, establishing short and long-rang operational and strategic plans, and delivering results within tight project deadlines.
• Demonstrated ability to manage supplier relationships for clinical and, in the future, commercial manufacturing, including relationship building, improvement of execution deliverables and contract negotiation.
• Experience in overseeing manufacturing/labeling/packaging for global markets to support product launch and commercialization is required.
• Proven understanding of US, EU, and ICH distribution requirements and industry best practices. Experience in Japanese regulations and requirements preferred.
• Outstanding interpersonal verbal, written, and presentation skills in communication with internal and external colleagues and partners.
• Strong analytical, decision-making, project management and problem-solving skills
• Ability to navigate through ambiguity, rapid growth, and adapt to change
• Ability to accommodate domestic and international travel at the request of the business (approximately 25-30%).